University of Wisconsin–Madison

Section III: Human Subjects Protection and HIPAA Compliance

Although not everyone at IRP works with confidential data or directly with research subjects, IRP expects employees to understand the rules regulating the protection of human research subjects.

Required UW Human Subjects Training (CITI)

The human subjects protection training, offered online by the University of Wisconsin–Madison, helps with everyday awareness of how certain information is used and distributed in order to minimize the risks to human subjects in research.

If your project(s) constitutes human subjects research, which means the project must be approved by a UW (IRB) Institutional Review Board, you are required to complete the online training.

For more information and a link to the training, see: https://kb.wisc.edu/gsadminkb/page.php?id=32559

 

Additionally, the UW requires that all individuals listed on human subject protocols required to fill out an annual Outside Activities Report (OAR) and update whenever new outside activities are undertaken.

Link to VCRGE Outside Activities Reporting: research.wisc.edu/compliance-policy/outside-activities-reporting/

 

Note that non-UW collaborators do not need to complete the UW course, but can provide certification of human subjects training from their own institution.  OARs are required only of UW students, staff, and faculty.

Required UW HIPAA Training (Canvas)

For all individuals who access IRP directory space on WinLDS, as well as all project PIs, the UW HIPAA training must be completed.

IRP space on WinLDS contains data with Protected Health Information.  Not all projects or individuals have access to this type of data.  However, because PHI data are stored on the server, IRP is requiring all those with WinLDS access (to IRP directories) to take the UW HIPAA training.

The HIPAA training must be renewed annually.

While IRP is not within the UW Health Care Component (HCC), the UW Privacy Office holds our researchers using PHI to the same standards applied to those within the HCC.

Please self-enroll here for the HIPAA training, provided by the Office of Compliance: https://compliance.wisc.edu/hipaa/training/

 

Note that non-UW collaborators do not need to complete the UW course, but can provide certification of HIPAA training from their own institution.

With the understanding that WinLDS users of IRP data will need to complete UW HIPAA training, and likely the UW human subjects training and an OAR, please continue to SECTION IV of the manual.